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Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

Primary Purpose

Bradyarrhythmia, Cardiac Arrest, Tachycardia

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Normal Saline
Glycopyrrolate
Sponsored by
National Academy of Medical Sciences, Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bradyarrhythmia focused on measuring Glycopyrrolate, Bradyarrhythmia, Laparoscopy, Pneumoperitoneum, Cardiac Arrest

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients of either sex aged 15-65 years Patient undergoing elective laparoscopic cholecystectomy American Society of Anesthesiologists (ASA) physical status I Exclusion Criteria: Patients with history of recent or past cardiac diseases Patients with pre-operative heart rate ≤60beats/min. Patients on cardiac medications Allergic to Glycopyrrolate

Sites / Locations

  • National Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Glyco

Arm Description

31 participants received 1ml of Normal Saline

31 participants received 1ml (0.2mg) of Glycopyrrolate

Outcomes

Primary Outcome Measures

Heart Rate (Bradycardia)
The primary outcome will be Bradycardia defined as heart rate below 60beats per minute

Secondary Outcome Measures

Systolic Blood Pressure
Monitoring of systolic Blood pressure
Diastolic Blood Pressure
Monitoring of diastolic Blood pressure
Mean Arterial Pressure
Monitoring of Mean Arteria pressure

Full Information

First Posted
August 1, 2023
Last Updated
August 24, 2023
Sponsor
National Academy of Medical Sciences, Nepal
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1. Study Identification

Unique Protocol Identification Number
NCT05997004
Brief Title
Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy
Official Title
Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 20, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Academy of Medical Sciences, Nepal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to evaluate the incidence of bradycardia during laparoscopic cholecystectomy. The main question[s] it aims to answer are: Does bradycardia really occurs during pneumoperitoneum/laparoscopic surgery? If the patient get Glycopyrrolate, Does it really prevent pneumoperitoneum/laparoscopic surgery induced bradycardia?
Detailed Description
The emergence of laparoscopic surgery has changed the way of approach for several organs. Despite several advantages, laparoscopic surgery may result in serious complications due to the physiologic changes which occur during the procedure. The cardiovascular system is one of the most challenged systems of the human body during laparoscopy. The insufflation of gas into the peritoneal cavity can provoke arrhythmias. Their incidence is as high as 14-27% of laparoscopies which is higher than in 'open' surgery. The life-threatening bradyarrhythmia (sinus bradycardia, nodal rhythm, atrio-ventricular dissociation and asystole) are frequently encountered during laparoscopic procedure which are due to a vagal-mediated cardiovascular reflex initiated by rapid stretching of the peritoneum at the beginning of peritoneal insufflation. There are studies addressing measures to prevent or control cardiovascular catastrophes during laparoscopic cholecystectomy. Some studies suggest administration of anticholinergic agents especially glycopyrrolate and atropine for prevention of bradycardia during intra-abdominal laparoscopic surgeries. Whereas some study suggests judicious use of Atropine as it increases the risk of tachyarrhythmia. Glycopyrrolate is a synthetic anticholinergic commonly used as a preoperative antimuscarinic agent to reduce salivary, tracheobronchial, and pharyngeal secretions, to reduce the volume and free acidity of gastric secretions, and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. HYPOTHESIS Glycopyrrolate administration reduces the incidence of bradycardia during Laparoscopic Cholecystectomy. General objectives To evaluate the role of Glycopyrrolate on prevention of bradyarrhythmia during Laparoscopic cholecystectomy. Specific objective To evaluate the change in heart rate and rhythm at different time interval after pneumoperitoneum. To evaluate the change in Systolic, diastolic and Mean arterial blood pressure at different time interval after pneumoperitoneum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradyarrhythmia, Cardiac Arrest, Tachycardia, Asystole
Keywords
Glycopyrrolate, Bradyarrhythmia, Laparoscopy, Pneumoperitoneum, Cardiac Arrest

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were randomly assigned to two groups having 31 in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
31 participants received 1ml of Normal Saline
Arm Title
Glyco
Arm Type
Experimental
Arm Description
31 participants received 1ml (0.2mg) of Glycopyrrolate
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
After surgical creation of umbilical port Control group received injection normal saline 1ml.
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Intervention Description
After surgical creation of umbilical port Group II received injection Glycopyrrolate 1ml=0.2mg
Primary Outcome Measure Information:
Title
Heart Rate (Bradycardia)
Description
The primary outcome will be Bradycardia defined as heart rate below 60beats per minute
Time Frame
Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
Secondary Outcome Measure Information:
Title
Systolic Blood Pressure
Description
Monitoring of systolic Blood pressure
Time Frame
Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
Title
Diastolic Blood Pressure
Description
Monitoring of diastolic Blood pressure
Time Frame
Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)
Title
Mean Arterial Pressure
Description
Monitoring of Mean Arteria pressure
Time Frame
Starting at 1minutes after creation of pneumoperitoneum up to Extubation (Recorded at 1,3,5,10,20,30,40,50 minutes after pneumoperitoneum and before and after extubation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients of either sex aged 15-65 years Patient undergoing elective laparoscopic cholecystectomy American Society of Anesthesiologists (ASA) physical status I Exclusion Criteria: Patients with history of recent or past cardiac diseases Patients with pre-operative heart rate ≤60beats/min. Patients on cardiac medications Allergic to Glycopyrrolate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brihaspati K C, MD
Organizational Affiliation
NAMS Bir Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brahmadev Jha, MD
Organizational Affiliation
NAMS Bir Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Surendra Bhusal, MD
Organizational Affiliation
NAMS Bir Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
National Academy of Medical Sciences
City
Kathmandu
Country
Nepal

12. IPD Sharing Statement

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Glycopyrrolate Prophylaxis for Prevention of Bradyarrhythmia During Laparoscopic Cholecystectomy

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